Implants that facilitate tissue expansion

ABSTRACT

The invention pertains to implants that facilitate tissue expansion while not substantially inhibiting normal anatomical movement. The implants may be made of different materials or made in different configurations such that such that a measured property at a first location on said implant is different than said same measured property at a second location on said implant. In one particular embodiment the implants may be a cosmetic penile implant.

CROSS REFERENCE TO RELATED APPLICATIONS

The instant application claims priority to U.S. Ser. No. 62/702,062filed Jul. 23, 2018 and U.S. Ser. No. 62/779,825 filed Dec. 14, 2018.The aforementioned applications are incorporated by reference for U.S.purposes.

BACKGROUND AND SUMMARY OF INVENTION

Cosmetic implants such as breast implants and penile implants aregrowing in popularity. Similarly, prosthetic and other medical devicesare increasingly employed to treat or ameliorate conditions. For bothimplants and other medical devices it is often desired that they conformto existing tissue and/or mimic normal anatomical movement such thatthey resemble the natural human or animal body part or even have anenhanced appearance relative to the natural human or animal body part.Unfortunately, implants and devices made using conventional technologyoften results in an implant or device which does not facilitate tissueexpansion, inhibits normal anatomical movement, and/or does not resemblea natural body party. Thus, what is needed is an implant thataccomplishes one or more of the aforementioned desirablecharacteristics.

Advantageously, the instant invention implants and medical devicesovercome the problems described above. The implants typically compriseone or more biocompatible materials. Advantageously, in some embodimentsthe one or more materials may be selected or configured to facilitatetissue expansion while not substantially inhibiting normal anatomicalmovement. The implants also may advantageously resemble a natural bodyparty or even have an enhanced appearance relative to a natural bodypart. Thus, the concepts of the instant invention are applicable to, forexample, breast implants, penile implants, testicular implants as wellas, incontinence devices such as male or female urethal continenceplugs.

The above-described concepts may be particularly useful with respect tocosmetic penile implants because currently available cosmetic penileenhancement devices suffer from a number of limitations anddeficiencies. Some comprise a rigid, inelastic silicone block thatincreases the risk of external erosion, patient discomfort, and anunnatural flaccid penile look and feel. Infection rates are alsoarguably higher with currently available cosmetic penile implantsbecause none are antibiotic-coated or antimicrobial-resistant.Additionally, the current cosmetic penile implants are implanted usingnon-absorbable sutures near the dorsal neurovascular bundle distally,risking penile devascularization and denervation that can produce penilenecrosis or reduced penile sensation. Further, the rigid silicone blockand non-absorbable sutures prevent full penile elasticity during anerection that can reduce potency and cause discomfort during anerection.

Accordingly, in one specific embodiment the instant invention pertainsto a penile implant. The penile implant generally comprises a bodyhaving outer and inner surfaces and a longitudinal axis and of aselected longitudinal length to be aligned with the long axis of apenis. The body comprises a cross-section perpendicular to thelongitudinal axis of the body having a wall thickness that taperscircumferentially in opposite directions beginning from a maximumthickness along a dorsal midline to a minimum thickness along ventraledges that form a ventral opening. Advantageously, the penile implantcomprises one or more biocompatible materials selected or configured tofacilitate tissue expansion.

The improved cosmetic penile implant of the present invention greatlyreduces these untoward complications and provides the patient with asafer, more comfortable, and more natural cosmetic penile enhancementwhile safeguarding natural penile sexual function. Thus, the cosmeticpenile implant implanted subcutaneously may be configured to replicateas nearly as possible the natural human anatomy in shape, appearance,elasticity, compressibility, texture, and feel.

These and other embodiments are described in detail below.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a perspective view of an embodiment of a penileimplant.

FIG. 2 illustrates a side view of the implant shown in FIG. 1.

FIG. 3 illustrates a section view of a proximal end of the implant shownin FIG. 2.

FIG. 4 illustrates a section view of a distal end of the implant shownin FIG. 2.

FIG. 5 illustrates a distal end view of the implant shown in FIG. 1.

FIG. 6 illustrates a proximal end view of the implant shown in FIG. 1.

FIG. 7 illustrates a section view of the implant shown in FIG. 5.

FIG. 8 shows a section of the natural anatomy of a penis.

FIGS. 9A and 9B illustrates perspective views of each side of anembodiment of a penile implant.

FIG. 10 illustrates various representative dimensions of various sizepenile implants.

FIG. 11 illustrates representative mesh tab locations for the penileimplant shown in FIGS. 9A and 9B.

FIG. 12 illustrates Shore Hardness scale and representative propertiesof various implants.

FIG. 13 shows representative mesh material options.

FIGS. 14A, 14B, and 14C illustrate penile implant location, method, andsizing embodiments.

FIG. 15 shows various configurations of the internal pockets of animplant core.

DETAILED DESCRIPTION OF THE INVENTION General Implant—Description ofImplants Methods of Making, Materials, Configurations, Characteristics(Cosmetic and Physical), Specific Implant Types

As described above, the implants and devices of this invention may besuitable for animals or humans. The specific material or materialsemployed will vary depending upon the specific implant, application,desired characteristics, and the like. In many applications the materialemployed will be biocompatible, i.e., not particularly harmful to thetissue that is near or in communication with the device or implantwhether it be human or animal tissue. The one or more materials aretypically selected, configured, or both to facilitate tissue expansionwhile not substantially inhibiting normal anatomical movement and/orsubstantially mimicking soft tissue characteristics of the natural bodypart. Of course, the selected one or more materials and the specificconfiguration will vary depending upon the specific implant and desiredtissue expansion and/or other results.

In one embodiment, to facilitate tissue expansion while notsubstantially inhibiting normal anatomical movement the implantcomprises one or more biocompatible materials selected or configuredsuch that a measured property at a first location on said implant isdifferent than said same measured property at a second location on saidimplant. Of course, using the present invention a measured property maybe different at three or four or any number of locations on the implant.That is, the implant could, for example, exhibit a gradient, i.e., anincrease or decrease in the magnitude of a measured property (e.g.hardness (durometer) and other properties such as tensile strength; tearstrength; compressive strength; and elongation which also may bereferred to as extensibility or stretching or elasticity) that isobserved in passing from one point or location on the implant toanother. This can be accomplished in at least two general ways or acombination of these two.

First, the material employed may be different at the first, second,and/or other additional locations of the implant. That is, the materialor materials employed may vary at the first, second, and/or otherlocations of the implant with respect to a property of interest for theimplant. That is the material or materials of the implant may bedifferent with respect to, for example, one or more, two one or more,three one or more, four one or more, or even five of the followingproperties: (1) hardness; (2) tensile strength; (3) tear strength; (4)compressive strength; and (5) elongation.

Making an implant having different properties at different locations onthe implant may be accomplished in any convenient manner, e.g., by usingdifferent material of different properties. Such manners will differbased on the implant, its properties, materials employed, and desiredcharacteristics.

Suitable methods may include molding, e.g., injection molding,extrusion, rotomolding, transfer molding, compression molding, blowmolding, 3D printing, and the like. In general, any suitable process maybe employed so long as the desired material with the desired propertycan be placed at the desired locations on and/or within the implant. Forexample, if using injection molding one might use a mold in the shape ofthe desired implant. The mold may have multiple injection points, e.g.,two or more, three or more, four or more, or up to as many as necessaryor desired. In this manner different materials (or the same materialwith varying properties) may be injected through each injection port. Ifdesired, there may be compartments within the mold but oftencompartments are unnecessary as factors such as the different injectionpoints and timing of injection may control the ultimate placement of thevarious materials. In this manner, the implant can be designed ortailored to have different properties at different locations or placeson or within the implant. Thus, the desired properties such as (1)hardness; (2) tensile strength; (3) tear strength; (4) compressivestrength; and (5) elongation can be tailored throughout the implant byselecting the one or more biocompatible materials such that a measuredproperty at a first location on said implant is different than said samemeasured property at a second, third, fourth, or even additionallocations on said implant.

A second method of making an implant wherein a measured property at afirst location on said implant is different than said same measuredproperty at a second or even more locations involves configuring thematerial within the implant to achieve this. This second method can beused independent of the first method which uses varying materials or amaterial that varies in properties. Alternatively, the configuringdescribed further below may be done in in conjunction with the use ofvarying materials or the use of a material that varies in properties.

In some embodiments of this second method, the one or more materials areconfigured to comprise one or more internal pockets within the implant.Such pockets are void spaces within the implant. The design andconfiguration of the pockets or void spaces will vary depending upon thetype of implant and desired characteristics. For example, the implantgeometry, size, depth, and/or location of the pockets can be configuredto result in one or more of the following: (1) reduce rigidity of atleast a portion of the implant, (2) reduce the total weight of theimplant, (3) increase elongation (elasticity or extensibility) of atleast a portion of the implant, or (4) increase compressibility of atleast a portion of the implant. As a specific example, the internalpockets may comprise pockets to modify the measured compression orelongation at different places on or within the implant, i.e.,compression pockets, elongation pockets, or both. In a specificembodiment, the implant may be configured with internal pockets that,for example, permit elongation or stretching. For example, in someembodiments, the implant may be configured with internal pockets suchthat stretching of at least 10%, or at least 20%, or at least 40%, or atleast 60%, or at least 80%, or at least 100%, or at least 150%, or atleast 200% occurs compared to the same implant substrate (e.g., samepolymer in same shape) without internal pockets. On the other hand, theimplant may be configured with internal pockets such that stretching ofup to at most 500%, or at most 450%, or at most 400%, or at most 350%,or at most 300%, or at most 250% occurs compared to the same implantsubstrate (e.g., same polymer in same shape) without internal pockets.By stretching is meant to refer to either elongation in one direction orcompression in the other direction.

As stated above, the particular geometry of the internal pockets mayvary widely depending upon the desired results. In particularembodiments, the implant may be designed such that the internal pocketsof the implant may be in a honeycomb (e.g., polygonal such ashexagonal), a zig zag (WWWWW), or even an elliptical configuration. Inthis manner, the implant can be made such that a measured property at afirst location on said implant is different than said same measuredproperty at a second, third, fourth, or even additional locations onsaid implant. For example, the implant's hardness at a particularlocation will usually depend at least in part upon the nature and volumeof the pockets or voids beneath the location. That is, the greater thevolume of voids beneath a particular implant location, the softer theimplant may feel at that particular location. Thus, an implant may havea dense honeycomb at the distal end with a less dense honeycomb at theproximal end or a gradient or graduated honeycomb densities leading todifferent hardnesses and/or other properties over the length and/orvarious dimensions of the implant. Likewise, the geometry, size, depth,and/or location of the pockets beneath a particular location also affectand/or determine the other properties of the implant beneath thatlocation, e.g., tensile strength; tear strength; compressive strength;and elongation (extensibility or elasticity). In this manner, theconfiguration of the pockets can be tailored or designed to change theproperties at various locations on the implant. FIG. 15 shows variousconfigurations of the internal pockets of an implant core.

The desired configuration of the implant's pockets, if any, may beaccomplished in any convenient manner and such manners may differdepending upon the type of implant, material(s) employed, desiredproperties, and other factors. One way of configuring an implant isthrough the use of injection molding wherein the mold cavity may includea removable structure in the geometry of the desired pockets so thatwhen structure is removed pockets or voids exist within the moldedimplant. A commonly used injection molding method using a core, a cavityside A, and a cavity side B may be employed. Dual or multiple extrusion,3-D printing and other methods may also be used to make theaforementioned implant structures.

The specific material or materials employed for the implants herein arenot particularly limited so long as they are typically biocompatible andcan be made to have one or more, or two or more, or three or more, orfour or more, or all of the desired properties (e.g., hardness, tensilestrength; tear strength; compressive strength; and/or elongation) in thedesired ranges described herein for the implant. Thermosets,thermoplastics, elastomers, or combinations thereof may be employed.Useful thermoplastics may include nylon, polyethylene, polypropylene,and polystyrene while useful thermosets may include various epoxy resinsand phenolic resins in any form while preferred thermosets may includevarious gel colloids. Silicone and polyurethane may be particularlyuseful materials for some types of implants. Particularly preferredmaterials include foams, either solid or semi-solid, closed cell foamssuch as those comprising urethane, silicone, or mixtures thereof.

Particularly preferred configurations for various implants include thosethat comprise a wall having a varying wall thickness over one or moredimensions of the implant. Another preferred configuration is one inwhich the amount of materials employed within the implant are changedover one or more dimensions in a gradient such as by a changing orchanged honeycomb structure. By reducing the wall thickness oralternatively having more voids in perhaps a honeycomb structure overthe length of the implant the hardness or other properties may bechanged such the implant is similar to natural tissue and/or allowsnormal physiological movement while augmenting the size or otherwiseenhancing the appearance of the body part. In another embodiment theimplant comprises one or more biocompatible materials having both linearand radial compression capability. This may assist in tissue expansionand may also contribute to the implant being similar to natural tissueand/or allowing normal physiological movement while augmenting the sizeor otherwise enhancing the appearance of the body part.

The specific properties of the implant may vary depending upon thematerial(s) employed, their placement, and the configuration, e.g.,geometry, size, depth, or location of pockets, if any. In one embodimentthe implant comprises one or more biocompatible materials wherein aspecific location on the implant and/or the material has a durometerrange of from about 0, or from about 10, or from about 20, or from about30 up to at most about 70, or up to at most 60, or up to at most 50, orup to at most 40 durometer on the Shore A scale according to ASTMD2240-15.

Other useful properties of the implant that may be determined by thematerial or configured as desired may include elongation, tensilestrength, tear strength, compressibility or extensibility. Specifically,useful implant embodiments may comprise wherein the implant comprisesone or more biocompatible materials wherein a specific location on theimplant and/or the material employed has a tensile strength of from atleast about 200 psi, or at least about 300 psi, or at least about 350psi up to at most about 1000 psi, or up to at most about 800 psi, up toat most about 700 psi, or up to at most 600 psi according to ASTMD412-06. Similarly, the implant may comprise one or more biocompatiblematerials wherein a specific location on the implant and/or the materialemployed has an elongation of from at least about 400%, or at leastabout 500%, or at least about 600%, or at least about 700%, or at leastabout 800%, up to about 1200%, or up to about 1100%, or up to about1000% according to ASTM D412-06. Similarly, the implant may comprise oneor more biocompatible materials wherein a specific location on theimplant and/or the material employed has a tear strength of at leastabout 40 pounds per inch (ppi), or at least about 50 pounds per inch(ppi), or at least about 60 pounds per inch (ppi), or at least about 70pounds per inch (ppi), or at least about 80 pounds per inch (ppi), up toabout 200 ppi, or up to about 130 ppi, or up to about 120 ppi, or up toabout 110 ppi according to ASTM D624. The implants of the presentinvention may also comprise one or more biocompatible materials whereina specific location on the implant and/or the material employed has acompressibility and/or extensibility factor of from at least 0, or atleast 5, or at least 10, or at least 15, up to about 20, or up to about25%. Compression can be tested by, for example, ASTM D395-03.

In other embodiments of the instant invention the implants may compriseone or more biocompatible materials wherein a specific location on theimplant and/or the material employed has at least one, or at least two,or at least three, or at least four or more of the above-describedproperties.

The implants may comprise further materials depending upon the desiredproperties and application. For example, the implant may comprisehydrophilic or hydrophobic agents on the interior or exterior of theimplant. In one specific embodiment the implants have a hydrophilicagent on the exterior such that the implant is at least partiallyresistant to bacteria, viruses, and the like in that they cannot adhereto the surface. Such hydrophilic agents are not particularly limited anddepend upon the application. As such they may be selected from anycompatible material and applied in suitable amounts to achieve thedesired effect.

Other suitable additives to the interior and/or exterior of the implantcomprise a material capable of releasing heat and/or a material capableof absorbing heat. In this manner the implant or portions of the implantmay be made to be exothermic or endothermic based on exposure to one ormore stimuli.

As described above, the instant inventions are widely applicable to anynumber of types of implants and/or prosthetic or other medical devices.Specific embodiments may be particularly applicable to penile implant, atesticular implant, a female incontinence implant, a breast implant, orsimilar implants and devices. More specifically, the instant inventionsmay be particularly applicable to those applications wherein tissueexpansion is desired. Such applications include, but are not limited to,e.g., applications wherein desired tissue expansion includes being neara urinary meatus, a fossa navicularis, or a bladder neck when, forexample, said implant is intended for or placed in a human. Particularlypreferred applications may include, for example, those wherein theimplant may be a penile implant, a male or female incontinence implantor plug, or a breast implant. Of course, the method of placing,attaching, inserting, and/or employing the implants of the instantinvention will vary depending upon the specific type of implant and theperson or animal's anatomy with which it will be employed. In mostinstances conventional and known surgical techniques or concepts can beemployed with a given implant. A specific embodiment pertaining to acosmetic penile implant is described below.

Specific Penile Implant Embodiments

The following specific embodiments disclosed relate to cosmetic penileimplants and method of implanting. However, it should be understood thatthe concepts, materials, properties, methods of making, and otherdescription above apply equally to cosmetic penile implants. Similarly,the concepts, materials, properties, methods of making, and otherdescription specific to the penile implant embodiment described belowmay also be applicable to many other types of implants and/orprostheses.

FIG. 8 illustrates a cross-section of the natural penile anatomyconsisting of several distinguishable parts. The glans penis is commonlyreferred to as the head of the penis. The skin 16 is the outer layer ofthe penis. The corpus cavernosum 10 are two columns of spongy erectiletissue comprising the dorsum of the penis bilaterally which, when filledwith blood, cause an erection. The corpus spongiosum 15 is a column ofsponge-like tissue comprising the medial ventrum of the penissurrounding the urethra 18 from the bladder neck to the glans peniswhich also fills with blood during an erection, but does not contributeto the erection. The paired corpora cavernosa 10 and the corpusspongiosum 15 are enclosed within a tube of deep fascia 20 called Buck'sfascia. Buck's fascia 20 also surrounds the deep dorsal vein 22, and thepaired dorsal arteries and dorsal nerves 24 of the penis.

The cosmetic penile implant may have a body having a longitudinal axisof a selected longitudinal length to be aligned with the long axis ofthe penis. The body may have any length and any diameter or width. Inone embodiment, the body may have a cylindrical cross section. In otherembodiments, the body may have an elliptical or oblong cross section. Inyet other embodiments, the body may have a cross section of any shape.The body has an outer surface and an inner surface. The body may beformed as one integral part. A cross-section perpendicular to thelongitudinal axis of the body may have a wall thickness that taperscircumferentially in opposite directions beginning from a maximumthickness along a dorsal midline to a minimum thickness along ventraledges that form a ventral opening. The ventral edges may be straight orscalloped edges. The body may be open at both its proximal end (nearestto the base of the penis), as well as the opposite distal end (nearestto the glans penis).

The body may also have a constant wall thickness in a directionextending longitudinally from the body's proximal end to the beginningof a distal portion at which point the wall thickness tapers from thebeginning of the distal portion to the body's distal end. A constantwall thickness extending along a longitudinal length of the body fromthe proximal end to the beginning of the distal portion is preferredover a tapered wall thickness because the constant wall thickness moreclosely matches the natural anatomy of the penis. The distal portion hasa tapered wall thickness only for a short portion near the distal end ofthe body (nearest the glans penis). The body may have all edges andcorners rounded, chamfered, or pillowed. The implant is configured tohave a size and shape adapted for subcutaneous implantation between theexterior skin and adjacent Buck's fascia. When implanted the device mayextend from the base of the penis at its proximal end to the glans penisat its distal end.

The body may be made of any type of polymer, elastomer, rubber,composite material, or any other spongy or flexible or compressivematerial that replicates as nearly as possible the natural human anatomyin shape, appearance, elasticity, compressibility, texture, and feel.The implant body material will be as flexible, compliant andcompressible to most closely simulate normal penile tissue in a flaccidstate while producing enhanced flaccid penile length and girth. In oneembodiment, the body may be made of a silicone. In another embodiment,the body may be made of polyurethane. The softness of the materialforming the body of the implant may have a Shore A softness of less than25, or less than 20, or less than 15, or less than 12, or morepreferably less than 10. A shore durometer measures hardness of amaterial, typically of polymers, elastomers, and rubbers. High numbersin its scale indicate a greater resistance to indentation, and thusharder materials. Lower number indicate softer, more compressible ormore flexible materials. There are several scales of durometer, used formaterials with different properties. The two most common scales, usingslightly different measurement systems, are the ASTM D2240 type A andtype D scales. The A scale is for softer materials, while the D scale isfor harder materials.

If desired, mesh tabs of from about 1 to about 2 cm in length may beplaced through the length of the lateral margins spaced from about 0.75cm to about 1.25 cm apart. The body may have one or more embedded tabs,e.g., mesh tabs, protruding from its proximal end, and one or moreembedded mesh tabs protruding from its distal end. The mesh tabs mayprotrude beyond the proximal end and the distal end up to any distance.For example, the embedded mesh tabs may protrude bilaterally (on bothsides) up to 0.5 cm beyond the distal end, or up to 1.0 cm beyond thedistal end, or up to 1.5 cm beyond the distal end, or greater. Theembedded mesh tabs may protrude bilaterally up 1.0 cm beyond theproximal end, or up to 1.5 cm beyond the proximal end, or up to 2.0 cmbeyond the proximal end, or greater. The mesh tabs may be any shape andsize, such as, for example, rectangular or square with right angles atedges, and are provided as a functional means for suturing the body atboth distal and proximal ends to Buck's fascia and the fibrous tunicalsheath of the corpus cavernosa, to support maintaining the body in placeand prevent longitudinal and/or rotational migration. The mesh tabs areconfigured to receive tissue ingrowth and may be made of any materialand mesh size that supports and promotes natural tissue ingrowth. Forexample, the mesh may be polyurethane mesh. Or the mesh may be anotherother type of material commonly used in reconstructive general, plastic,or urologic surgery as will be understood by one of ordinary skill inthe art. Absorbable sutures may be used to fasten the mesh tabs toBuck's fascia and the corpus cavernosa tunic. Suturing will beunderstood by one of ordinary skill in the art. The mesh tabs may beformed integrally with the body, or embedded within the body, orattached to it, or attached between multiple layers of the body, orattached to the body by other methods of attachment. The mesh tabs arelocated at the proximal end and the tapered distal end as near theventral margin as possible. Mesh tabs are not located within or attachedto the body along or near the dorsal midline to avoid suturing or tissueingrowth near the dorsal neurovascular bundle, which would riskdenervation or devascularization of the penis both during implantationor during any subsequent required explanation.

The body may have an antimicrobial surface coating that contains anantimicrobial agent that inhibits the ability of microorganisms to growon the surface of the body. For example, an antibiotic or antibacterialmay coat the surface or be embedded into the implant material andthereby potentially reduce the risk of bacterial infections of theimplant. In one embodiment, the body may be dipped into an antibiotic orantibacterial agent to coat the surfaces. In another embodiment, thebody may be impregnated with an antibiotic or antibacterial agent whenthe body is formed. The antibiotic coating or impregnation of the bodywill be consistent with bioprosthesis standards as will be understood byone ordinarily skilled in the art. Any type of antibiotic orantibacterial agent may be used. For example, in certain embodiments,Rifampin and/or Minocycline may be used.

FIGS. 1-7 illustrate an embodiment of a penile implant 100. FIG. 1illustrates a perspective view of an embodiment of the penile implant100. FIGS. 2 and 7 illustrate side and cross section views of the penileimplant 100, respectively. The implant 100 has a cylindrical body 110having a longitudinal axis and of a selected longitudinal length to bealigned with the long axis of the penis. The cylindrical body 110 has anouter cylindrical surface 112 and a smaller inner cylindrical surface114. FIGS. 3 and 4 illustrate cross-section views perpendicular to thelongitudinal axis of the cylindrical body 110. The cylindrical body 110has a wall thickness that tapers circumferentially in oppositedirections beginning from a maximum thickness along a dorsal midline 120to a minimum thickness along ventral edges 122 that form a ventralopening 124. The ventral edges 122 are illustrated as scalloped, howeverthey may also be straight edges.

FIG. 5 illustrates a distal end view, FIG. 6 illustrates a proximal endview of the penile implant 100. The cylindrical body 110 may be open atboth its proximal end 116 (nearest to the base of the penis), as well asthe opposite distal end 119 (nearest to the glans penis). The body 110may also have a constant wall thickness in a direction extendinglongitudinally from the body's proximal end 116 to the beginning 117 ofa distal portion 118 where the wall thickness tapers from the beginning117 of the distal portion 118 to the distal end 119 of the cylindricalbody 110. The distal portion 118 has a tapered wall thickness from thebeginning 117 of the distal portion 118 to the distal end 119 of thecylindrical body 110 (nearest the glans penis). The cylindrical body 110may have pillowed or rounded edges 128 at both the proximal end 116 andthe distal end 119. The implant 100 is configured to have a size andshape adapted for subcutaneous implantation between the exterior skin 16and adjacent to Buck's fascia 20. The implant may extend from the baseof the penis at its proximal end to the glans penis at its distal end.

The cylindrical body 110 further includes embedded mesh tabs 128 thatare located at its proximal end 116, and one or more embedded mesh tabs128 that are located at its distal end 119. The mesh tabs 128 areconfigured to receive tissue ingrowth and provide a functional means forsuturing the cylindrical body at both distal 119 and proximal ends 116to Buck's fascia 20 to keep the cylindrical body 110 in place andprevent longitudinal and/or rotational migration. Absorbable sutures maybe used to fasten the mesh tabs to Buck's fascia and the underlyingtunic of the corpus cavernosum. The mesh tabs 128 may be formedintegrally with or embedded within the cylindrical body 110, or attachedto it, or secured between multiple layers of the cylindrical body 110,or secured to the cylindrical body 110 by another other methods ofattachment. The mesh tabs 128 are located at the proximal end 116 anddistal end 119 as near the ventral edges 122 as possible. Mesh tabs 128are not located within or attached to the body 110 along or near thedorsal midline to avoid suturing or tissue ingrowth near the dorsalneurovascular bundle 22, 24, which would risk denervation ordevascularization of the penis.

The following methods may be used for implanting the cosmetic penileimplant. The cosmetic penile implant may be placed through apeno-scrotal or ventral phalloplasty incision without an abdominalincision being made and without associated surgical drain placement.Through a peno-scrotal or ventral phalloplasty incision, Buck's fasciaoverlying the fibrous tunic of the corpus cavernosa is identified andthe soft tissue attachments are released through both blunt and sharpdissection. Care is taken to avoid disruption of Buck's fascia along thedorso-lateral margins of the corpus cavernosa to avoid injury to theunderlying penile neurovascular bundle, thereby avoiding risk of peniledevascularization or sensory denervation. Through this incision, theglans penis may be retracted caudally, thereby inverting the penileshaft and permitting direct inspection and additional dissection of thedistal penile shaft. The distal implant margin containing the mesh tabsmay then be secured lateral to the dorsal neurovascular bundle usingabsorbable sutures, ensuring secure and proper placement of the implant.Similarly, absorbable sutures may be used to secure the proximal marginof the implant ventrally, permitting tissue ingrowth at each position ofthe implant at all four quadrants. This additionally secures the implantin the desired location and reduces the risk of implant migration,malposition and erosion. This surgical approach also facilitates,through direct inspection, ventral placement of the implant lateral tothe urethral margin bilaterally, further ensuring not only properimplant placement, but a more concealed and comfortable tapered lateralimplant margin. The wound and the implant can be copiously irrigatedwith antibiotic solution and hemostasis achieved and confirmed beforethe subcutaneous tissue is reapproximated, also with absorbable sutures.The peno-scrotal skin is similarly reapproximated with absorbablesutures providing a two-layered closure. The shaft is then looselywrapped with gauze and elastic adhesive, taking care to avoid penileischemia. The patient may be discharged the same day following a briefrecovery period with instructions to remove the dressing in 24-48 hours.Cleansing of the wound daily may then occur. Avoidance of sexualintercourse is advised until the one month postoperative examination.

Another method of implanting the cosmetic penile implant may be themethods that are taught by U.S. Pat. No. 4,202,530, which isincorporated herein by reference in its entirety.

The inflatable penile implant to correct erectile dysfunction may besubsequently implanted within the corpus cavernosa, deep to the cosmeticpenile implant, without meaningful physical alteration to the cosmeticpenile implant or compromise of the intended purpose of the cosmeticpenile implant. Similarly, placement of the cosmetic penile implantsubsequent to placement of an inflatable penile implant is possible witheither surgical approach referenced above. Advantageously, there are norestrictions to erection of the penis following cosmetic implantplacement given absorbable suture use, elasticity of the implant bodyand only segmental use of mesh attachments off the dorsal midlineneurovascular bundle.

FIGS. 9A and 9B illustrate an embodiment of a penile implant with aperspective view of each side. As shown in FIG. 10 the penile implant,like the other implants herein, can be made in a wide range of sizes anddimensions. Advantageously, the wall thicknesses may vary over thelength of the implant and/or the geometry and configuration can beadjusted with pockets as described above. By subtraction of materialusing thinner walls and/or by adding more pockets, one can change thehardness over the various dimensions of the implant. Thus, the hardnessand other properties may change from proximal to distal and vice versa,e.g., the distal portion may have a dense honeycomb structure while theproximal portion is less dense. This assists in, for example, providingaugmentation while retaining physiological feel and function. That is,the penile and other implants of the present invention may mimic softtissue more so than other implants which may, for example, employ abag-like or balloon like exterior with a cavity filled with fluid-likematerial. In contrast, the implants of the present invention may becomprised of a single material configured with pockets to adjust theproperties.

The penile and other implant may be attached in any convenient manner.As described previously in some embodiments the penile implant maycomprise tabs for suturing the penile or other implant to the body. Ifemployed, then the tabs may be located at any convenient location and becomprised of any biocompatible material. FIG. 11 illustratesrepresentative mesh tab locations for the penile implant shown in FIGS.9A and 9B while FIG. 13 shows exemplary types of mesh material that maybe employed.

As described in detail above, the implants, including the penileimplant, may be comprised of materials that exhibit various ranges ofproperties, e.g., durometer, elongation, tensile, tear, etc., at one ormore different locations on the implant. FIG. 12 illustrates ShoreHardness scale and representative properties of various implants such asthe penile implant. FIGS. 14A, 14B, and 14C illustrate penile implantlocation, method, and sizing embodiments. If course, if desired one ormore of various other features may be incorporated into the penile orother implants so long as they don't substantially interfere with thefunction. A non-limiting list of such features may include ribs, knobs,horns, grooves, a radiopaque property, fluorescence or some otherilluminating property.

The claimed subject matter is not to be limited in scope by the specificembodiments described herein. Indeed, various modifications of theinvention in addition to those described herein will become apparent tothose skilled in the art from the foregoing description. Suchmodifications are intended to fall within the scope of the appendedclaims.

What is claimed is:
 1. An implant suitable for a desired animal or human body part or portion thereof wherein the implant comprises an implant body comprising one or more biocompatible materials wherein said one or more materials are selected or configured to facilitate tissue expansion while not substantially inhibiting normal anatomical movement and wherein said one or more biocompatible materials comprise internal pockets of inaccessible enclosed void spaces within the implant body configured such that a measured property of hardness at a first location on said implant is different than said same measured property at a second location on said implant.
 2. The implant of claim 1 wherein at least one additional measured property at a first location on said implant is different than said same measured property at a second location on said implant.
 3. The implant of claim 2 wherein said additional measured property comprises one or more of the following properties: (1) tensile strength; (2) tear strength; (3) compressive strength; and (4) elongation.
 4. The implant of claim 1 wherein said implant comprises one or more biocompatible materials having both linear and radial compression capability.
 5. The implant of claim 1 wherein said implant comprises one or more biocompatible materials having a durometer range of from about 0 to about 70 durometer on the Shore A scale.
 6. The implant of claim 1 wherein said implant comprises one or more biocompatible materials having a tensile strength of from about 200 psi to about 800 psi.
 7. The implant of claim 1 wherein said implant comprises one or more biocompatible materials having an elongation of from about 600% to about 1200%.
 8. The implant of claim 1 wherein said implant comprises one or more biocompatible materials having a tear strength of from about 40 pounds per inch (ppi) to about 130 ppi.
 9. The implant of claim 1 wherein said implant comprises one or more biocompatible materials having a compressibility and extensibility factor of up to about 25%.
 10. The implant of claim 1 wherein said implant comprises one or more biocompatible materials having two or more of the following: (1) a durometer range of from about 0 to about 70 durometer; (2) a tensile strength of from about 200 psi to about 800 psi; an elongation of from about 600% to about 1200%; (3) a tear strength of from about 40 ppi to about 130 ppi; and (4) a compressibility and extensibility factor of up to about 25%.
 11. The implant of claim 1 wherein said implant further comprises a hydrophilic agent.
 12. The implant of claim 1 wherein said implant comprises a wall having a varying wall thickness.
 13. The implant of claim 1 wherein said internal pockets vary in one or more of the following: geometry, size, depth, or location.
 14. The implant of claim 13 wherein the said internal pockets are configured to result in one or more of the following: (1) reduce rigidity of at least a portion of the implant, (2) reduce the total weight of the implant, (3) increase elasticity of at least a portion of the implant, (4) increase extensibility of at least a portion of the implant, or (5) increase compressibility of at least a portion of the implant.
 15. The implant of claim 13 wherein said internal pockets comprise those selected from compression pockets, elongation pockets, or both.
 16. The implant of claim 15 wherein said internal pockets permit stretching of up to 500% compared to the same implant substrate (e.g., same polymer in same shape) without internal pockets.
 17. The implant of claim 1 wherein said internal pockets comprise a honeycomb design.
 18. The implant of claim 1 wherein said biocompatible material comprises a material that releases heat.
 19. The implant of claim 1 wherein said biocompatible material comprises a material that absorbs heat.
 20. The implant of claim 1 wherein one or more biocompatible materials have two or more of the following: (1) a durometer range of from about 10 to about 70 durometer; (2) a tensile strength of from about 200 psi to about 800 psi; an elongation of from about 600% to about 1200%; (3) a tear strength of from about 40 ppi to about 130 ppi; and (4) a compressibility and extensibility factor of up to about 25%.
 21. The implant of claim 1 wherein the implant is configured in the form of a penis, testicle, or a breast.
 22. The implant of claim 1 wherein the implant is configured in the form of a breast. 